Effects of AHCL Insulin Pump on Glycemic Control and Psychosocial Outcomes in Pediatric Patients With Type 1 Diabetes

Seoul National University

Status: Enrolling

Conditions: Type 1 Diabetes

Treatments: Device: Medtronic 780G insulin pump

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06414564

23081591461

Details and patient eligibility

About

Prospective, non-randomized, single-arm clinical trial to investigate the effects of advanced hybrid close-loop (AHCL) system insulin pump in pediatric patients with type 1 diabetes

Full description

This trial consists of baseline phase of 3 weeks sustaining the treatment previously maintained by the patient, followed by study phase of 12 weeks of AHCL system application.

Enrollment: 30 estimated patients

Sex: All

Ages: 7 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The subject is age 7-19

2. The subject with one or more of the below

   • serum c-peptide ≤ 0.6 ng/mL at diagnosis
   • positive glutamic acid decarboxylase (GAD) antibody
   • positive islet cell antibody
   • positive anti-Insulin antibody
   • positive anti-islet Antigen-2 (IA-2) antibody

3. The subject was diagnosed with type 1 diabetes ≥ 1 year

4. The subject has been continuously treated at least for 8 weeks at the start of the study, by one of the existing insulin treatment methods [insulin multi-injection (MDII), general insulin pump (CSII), sensor-linked insulin pump (SAP), or 770G insulin pump (HCL system)]

5. The subject has been applied with real-time continuous glucose monitoring at least for 8 weeks at the start of the study

Exclusion criteria

1. Any systemic treatment with drugs known to interfere with glucose metabolism within 8 weeks prior to trial
2. Subjects with underlying hematologic disorders that can affect the HbA1c levels
3. Subjects with underlying medical disorders that can affect glucose metabolism
4. Subjects with a neuropsychiatric disorder such as depression or eating disorder
5. Subjects with underlying thyroid disorders and abnormal thyroid function

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 1 patient group

AHCL system application

Experimental group

Description:

insulin infusion using AHCL system insulin pump (Medtronic 780G) with continous glucose monitoring (guardian G4)

Treatment:

Device: Medtronic 780G insulin pump